# K990462: IS H. Pylori Igg Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Columbia Bioscience, Inc.
- Decided: Sep 3, 1999 after 203 days
- Product code: LYR (Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wampole H. pylori 1gG ELISA: named in the summary without a submission number

## Indications for use
For the qualitative determination of 1gG antibodies to Helicobactor pylori antigen in human sera by indirect enzyme immunoassay. The H.pylori 1gG assay may be used as an aid in the diagnosis of A. pylori infection in adult patients with gastrointestinal symptoms. The test can be performed either manually or in conjunction with the MAGO® PLUS Automated EIA Processor.

Source page: https://510kreport.com/device/K990462
Methodology: https://510kreport.com/methodology